Events

Recall of Device Recall Zimmer Tivanium Self Tapping Screw

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Zimmer Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    50694
  • Event Risk Class
    Class 2
  • Event Number
    Z-0904-2009
  • Event Initiated Date
    2008-12-12
  • Event Date Posted
    2009-01-26
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2009-10-30
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=76130
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Self Tapping Bone Screw - Product Code HWC
  • Reason
    The package may contain a 40 mm long screw instead of the labeled 42 mm long screw, or vice versa.
  • Action
    The firm's facility in Japan was notified via letter, "Urgent: Device Recall" (dated 12/11/08) and requested to complete an enclosed Inventory Return Certification form. The letter instructed distributors to notify accounts to the user level to stop using the affected implants and return them to the Zimmer Distribution Center in the U.S. and fax (574-372-4265) a copy of the completed Inventory Return Certification form to Zimmer, Inc. For questions about the recall, please contact Zimmer, Inc. at 1-800-613-6131.

Device

Device Recall Zimmer Tivanium Self Tapping Screw
  • Model / Serial
    Lot 60557215.
  • Product Classification
    Orthopedic Devices
  • Device Class
    2
  • Implanted device?
    Yes
  • Distribution
    International Distribution including country of Japan.
  • Product Description
    Zimmer TIV Self Tap Screw, 40 mm. Manufactured by Zimmer Manufacturing B.V., A Subsidiary of Zimmer, Inc., Warsaw, IN; Item No. 48231904000. NOTE: This product is not sold in the United States. || The device is used to attach healing plates to long bones for stabilization of fractures during the normal healing process. Devices are individually packaged and sold sterile.
  • Manufacturer
    Zimmer Inc.

Manufacturer

Zimmer Inc.
  • Manufacturer Address
    Zimmer Inc., 345 E Main St, Warsaw IN 46580-2746
  • Source
    USFDA